Sr Manager, Supplier Quality

Thermo Fisher Scientific • Rochester, NY

18d • Onsite

About The Position

As a Senior Manager of Supplier Quality at Thermo Fisher Scientific, you will guide the global supplier performance management program and elevate supplier quality standards. You will lead Supplier Quality Engineers and collaborate with cross-functional partners on continuous improvement, strategic supplier development, critical quality initiatives, stakeholder partnerships, and problem-solving for non-conformances. The position owns the supplier quality framework across the supplier lifecycle, regulatory compliance and supplier risk management, supplier audit and corrective action governance, and continuous improvement across the supplier network. It also leads team development and performance, supplier quality strategy, metrics, and cross-functional and supplier relationships. The work schedule is standard Monday through Friday. The role is office-based, may involve work in manufacturing environments requiring PPE including cleanroom gear, and requires up to 50% domestic and international travel.

Requirements

• Bachelor’s degree plus 8–10 years of experience, or an advanced degree plus 6 years of experience in medical device or pharmaceutical industry quality or regulatory affairs roles.
• At least 3 years of people management experience.
• Strong knowledge of ISO 13485 and 21 CFR Part 820 regulations.
• Experience with global regulatory agencies, including FDA, IVDR Notified Bodies, PMDA, ANVISA, and Health Canada.
• Proficiency in Six Sigma methodologies, including 8D, FMEA, DMAIC, Value Stream Mapping, and Pareto Analysis.
• Statistical analysis skills, including SPC, DOE, and sampling.
• Experience with quality management systems such as SAP and TrackWise.
• Strong understanding of supplier performance management principles.
• Excellent oral and written communication skills and fluency in English.
• Experience implementing global harmonization initiatives and managing matrix organizations across diverse cultures.
• Strong project management and strategic planning capabilities.
• Ability to build and maintain relationships with internal and external stakeholders.
• Willingness to travel up to 50% domestically and internationally.
• Ability to work in manufacturing environments requiring PPE, including cleanroom gear.
• Technical proficiency with IT databases and digital tools.
• Problem-solving mindset and experience implementing effective solutions.
• Experience working with commodities including machined parts, electrical components, plastics, resin, and chemicals.

Nice To Haves

• Quality Lead Auditor certification.
• Preferred fields of study include Engineering, Operations Management, or Biological Sciences.

Responsibilities

• Lead and develop the Supplier Quality team, including talent and succession planning, organizational capability building, performance management, coaching, and development plans.
• Translate business and quality priorities into team objectives, operating plans, and clear accountability; lead supplier quality strategy and organizational capabilities.
• Own the supplier quality framework from initial supplier assessment and qualification through ongoing monitoring and improvement.
• Ensure regulatory compliance and assess, prioritize, and address supplier risks across the supply chain.
• Define supplier quality metrics and review trends to guide priorities, resource allocation, technology adoption, and process improvements.
• Drive adoption of technologies and processes that strengthen supplier oversight and support material qualification, product changes, and sustaining engineering.
• Oversee quality improvement programs and lead initiatives and projects that improve supplier performance and product quality.
• Build strategic alignment with Sourcing, Manufacturing, Product Engineering, Global Technical Support, Operations, and Commodity Management to resolve systemic supplier quality challenges.
• Develop senior-level supplier relationships and engage supplier leadership in resolving systemic issues and improving quality capability.
• Plan and lead supplier quality audits, document findings, and follow up on corrective actions; own the supplier audit program and corrective action governance.
• Oversee the supplier nonconformance and corrective action system, ensuring timely containment, effective root cause analysis, and sustained corrective and preventive actions.
• Guide continuous improvement priorities across the supplier network, aligning projects and resources with business needs and quality risks.
• Maintain and analyze supplier quality and performance metrics to identify trends, investigate non-conformances, and conduct root cause analysis.
• Provide accountability for team performance, workload prioritization, management reviews, escalated supplier risks, supplier governance cadence, KPI targets, talent development, and supplier quality strategy execution.
• Execute cross-division harmonization initiatives and strengthen organizational capabilities.

Benefits

• Variable annual bonus based on company, team, and/or individual performance results, in accordance with company policy.
• Choice of national medical and dental plans and a national vision plan, including health incentive programs.
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement.
• At least 120 hours of paid time off (PTO) and 10 paid holidays annually.
• Paid parental leave, including 3 weeks for bonding and 8 weeks for caregiver leave.
• Accident and life insurance, and short- and long-term disability in accordance with company policy.
• Competitive 401(k) U.S. retirement savings plan.
• Employees’ Stock Purchase Plan, offering eligible colleagues the opportunity to purchase company stock at a discount.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior